MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIA

Catalog Number	KC-1101L
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint involved a patient who underwent a second knee revision surgery on (b)(6) 2017.The first revision occurred on (b)(6) 2013 and the original surgery is dated (b)(6) 2013.The revision surgery occurred because of instability in the knee and patient pain.During this revision, the original size 2 tibial baseplate, and size 1 femoral component were removed along with the size 1 x 20 mm insert and retaining bolt from the first revision surgery.The components were replaced with a new size 2 tibial baseplate, a size 1+ femur, a size 1 x 10 mm tibial insert and retaining bolt.In addition, two modular stems, four femoral augments and bolts, and two tibial augments and bolts were implanted.

• Brand Name: APEX KNEE SYSTEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
• Manufacturer (Section D): OMNILIFE SCIENCE, INC.; 480 paramount drive; raynham MA 02767
• MDR Report Key: 6340436
• Report Number: 1226188-2017-00009
• Device Sequence Number: 968756
• Product Code: JWH
• UDI-Device Identifier: 00841690100805
• UDI-Public: 00841690100805
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K060192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: KC-1101L
• Device Lot Number: 117247136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR